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Premature InfantNCT03505424

Supporting All Families of Premature Infants At Prentice Women's Hospital from Admission Through Discharge

A study testing Group 2: NICU2HOME app and Group 3: SMART NICU2HOME app in people with Premature Infant and Premature Birth, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to determine the extent to which the SMART NICU2HOME (including EMR interface) and the NICU2HOME apps, mobile applications designed for parents of premature infants to receive daily, real-time information about their infants and personalized education material based on parents'… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Premature Infant, Premature Birth, NICU
What is being tested?
Group 2: NICU2HOME app and Group 3: SMART NICU2HOME app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteUnited States
Study dates
20 Apr 2018to 30 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Parents of premature infants (<37 weeks) admitted to Prentice NICU
  • Competent in English (i.e. to fully understand the questions asked in the surveys)
  • Smartphone owner

Who cannot join

  • None Adults unable to consent/Cognitively Impaired
  • Pregnant women (where the activities of the research may affect the pregnancy or the fetus)
  • Prisoners or other detained individuals

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

Other trials in United States

About this study

The objective of this study is to determine the extent to which the SMART NICU2HOME (including EMR interface) and the NICU2HOME apps, mobile applications designed for parents of premature infants to receive daily, real-time information about their infants and personalized education material based on parents' anticipated concerns and their infant's clinical status, is effective in: 1) improving parents' competency in caring for their sick infants, 2) reducing stress, 3) supporting parents' social supports and 3) improving NICU outcomes (parent satisfaction, length of stay, readmission rates.)

Read the detailed description

There will be four groups of participants based on when the infant is in the NICU.

Parents of infants born from April -Mid-August 2018 (Group 1) Group 1 participants will receive usual care which includes 1) a welcome packet from the nursing staff, 2) access to their infant's medical team including doctors and nurse, 3) opportunities to ask any questions and understand the care their baby is receiving through participation in daily work rounds or through setting up family meetings with the medical team.

At NICU admission, parents in Group 1 will be asked to complete a brief demographics form and several standardized surveys that measure stress and life experiences. Surveys will again be administered 7-10 days later, the day before discharge, two weeks after discharge and 30 days after discharge. These surveys will be available both via on paper or an email link.

Parents of infants born from Mid-August - January 2019 (Group 2) At NICU admission, parents in Group 2 will be asked to complete a brief demographics form and several standardized surveys that measure stress and life experiences. Surveys will again be administered 7-10 days later, the day before discharge, two weeks after discharge and 30 days after discharge. These surveys will be available both via on paper or an email link.

In addition to the usual care made available to Group 1 and described above, Group 2 parents will also be asked to download the NICU2HOME app from a given website where they will enter MRN, DOB, name, gender, and due date of their infant into the smartphone app. In case there are difficulties downloading or using the app, the research team will be available to assist parents with any questions or concerns.

Parent of infants born from February 2019- June 2019 (Group 3) At NICU admission, parents in Group 3 will be asked to complete a brief demographics form and several standardized surveys that measure stress and life experiences. Surveys will again be administered 7-10 days later, the day before discharge, two weeks after discharge and 30 days after discharge. These surveys will be available both via on paper or an email link. In addition to the usual care made available to Group 1, Group 3 parents will also be asked to download the SMART NICU2HOME app from a given website where they will enter MRN, DOB, name, gender, and due date of their infant into the smartphone app.

Parent of infants born from November 2019- December 2020 (Group 4) At NICU admission, parents in Group 4 will be asked to complete a brief demographics form and several standardized surveys that measure stress and life experiences as well as parental efficacy. Surveys will again be administered 30 and 60 days later depending on the gestational age of the baby, the day of discharge, two weeks after discharge and 30 days after discharge. These surveys will be available through an email link.

In addition to the usual care made available to Group 1 and described above, Group 4 parents will also be asked to download the NICU2HOME app from a given website where they will enter MRN, DOB, name, gender, and due date of their infant into the smartphone app. In case there are difficulties downloading or using the app, the research team will be available to assist parents with any questions or concerns. Participants in Group 4 will not be paid for their contribution to the research.

Each participant (in both groups) will be asked to complete the surveys independently without sharing responses. If completed on paper, the research team will arrange either to pick the survey up at the NICU if the baby is still in the hospital, via a pre-paid stamped envelope provided, or over the phone. Online surveys will be automatically returned.

Optional Interview:

In addition to the intervention study, an optional qualitative interviews will be conducted with 30 families from group 2 and group 3 for about 30-45 minutes. Patients will have the option to opt to participate in the interviews when consenting to the main study by signing their initials on the "Optional Elements" to be interviewed. Consenting to be interviewed also means that they have agreed to let us audio record the interview for research purposes. Of those who opted to be interviewed, only 30 families will be randomly selected to partake in the interviews.

Using maximum variation sampling method, the interview will occur around 1-2 days prior to discharge (final thoughts, use patterns) with approximately 5 families per gestational age bracket: <28 weeks; 28-<30 weeks; 30-<32 weeks; 32-<34 weeks; 34-<37 weeks. The interviews will be semi-structured, one-on-one phone on in-person interviews (option is the family's) designed to elicit feature feedback reasons for their level of usage. With consent, all interviews will be audio-recorded, transcribed, coded, and analyzed for themes to improve further iterations. These audio recordings (either in voice or transcription) may be used in scholarly presentations or publications serve to help other professionals understand the research. No identifiers will be present when sharing the recordings to maintain anonymity, and recordings will be saved with a study ID number rather than name.

NICU2HOME app was created for parents of premature infants to meet their demands. The app will teach parents about their baby and the NICU. It will allow them to receive educational material every day that is specifically geared towards their baby's journey in the NICU. The app will also all parents to connect with their friends and family allowing them to privately and safely share and post among themselves.

SMART NICU2HOME app includes the same features and functions as the NICU2HOME app stated above; however, it also allows parents to receive a daily update of the clinically benign information of their infant directly from the EPIC EMR, such as, days of life, adjusted gestational age, weight, length, etc.

Being tested
Group 1: Standard of Care, Group 2: NICU2HOME app, Group 3: SMART NICU2HOME app
Keywords
Premature Infant, Premature Birth, Smartphone App, NICU
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group 1: Standard of CareOther

    Those who are in Group 1 will receive the usual care which includes:

    1. a welcome packet from the nursing staff
    2. access to their infant's medical team including doctors and nurse
    3. opportunities to ask any questions and understand the care their baby is receiving through participation in daily work rounds or through setting up family meetings with the medical team.
  • Group 2: NICU2HOME appOther

    In addition to the usual care made available to Group 1 as described above, Group 2 parents will receive the smartphone app. Group 2 parents will be asked to download the NICU2HOME app.

  • Group 3: SMART NICU2HOME appOther

    In addition to the usual care made available to Group 1 as described above, Group 2 parents will receive the smartphone app. Group 3 parents will be asked to download the SMART NICU2HOME app.

Study groups in NCT03505424
Study groupRoleWhat they receive
Group 1: Standard of CareActive comparatorParents of infants born from April -mid-August 2018 (Group 1)
Receives: Other: Group 1: Standard of Care
Group 2: NICU2HOME appActive comparatorParents of infants born from mid-August 2018- January 2019 (Group 2)
Receives: Other: Group 2: NICU2HOME app
Group 3: SMART NICU2HOME appActive comparatorParents of infants born from February- June 2019 (Group 3)
Receives: Other: Group 3: SMART NICU2HOME app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome measure will be the level of confidence caring for their premature infants while in the NICU and once at home measured through a survey.

    We will use the PSOC Survey for this outcome.

    Measured: 2-3 months

Secondary outcomes (2)
  1. The primary outcome measure will be the level of stress caring for their premature infants while in the NICU and once at home measured through a survey.

    We will use the PSS Survey for this outcome.

    Measured: 2-3 months

  2. Relationship quality will be measured through survey.

    We will use the MOS Survey for this outcome.

    Measured: 2-3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2018
  2. Study start20 Apr 2018
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03505424
Sponsor's protocol ID
STU00207127
Status last verified
Nov 2024
First submitted
30 Mar 2018
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hamilton BE Ph D, Martin JA, Osterman MJ M H S, Curtain SC M A. Births: Preliminary Data for 2014. Natl Vital Stat Rep. 2015 Jun;64(6):1-19.

    PubMed 26114874
  • Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes; Behrman RE, Butler AS, editors. Preterm Birth: Causes, Consequences, and Prevention. Washington (DC): National Academies Press (US); 2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK11362/

    PubMed 20669423
  • Garfield CF, Lee Y, Kim HN. Paternal and maternal concerns for their very low-birth-weight infants transitioning from the NICU to home. J Perinat Neonatal Nurs. 2014 Oct-Dec;28(4):305-12. doi: 10.1097/JPN.0000000000000021.

    PubMed 24927295
  • Obeidat HM, Bond EA, Callister LC. The parental experience of having an infant in the newborn intensive care unit. J Perinat Educ. 2009 Summer;18(3):23-9. doi: 10.1624/105812409X461199.

    PubMed 20514124
  • De Rouck S, Leys M. Information needs of parents of children admitted to a neonatal intensive care unit: a review of the literature (1990-2008). Patient Educ Couns. 2009 Aug;76(2):159-73. doi: 10.1016/j.pec.2009.01.014. Epub 2009 Mar 24.

    PubMed 19321288
  • Strauss, A.L., et al., Social organization of medical work. 2nd ed. 1997, New Brunswick, London: Transaction Publishers.

  • Glaser, B.G. and A.L. Strauss, Time for dying. 1968, Chicago, U.S.A.: Aldine

  • Ward K. Perceived needs of parents of critically ill infants in a neonatal intensive care unit (NICU). Pediatr Nurs. 2001 May-Jun;27(3):281-6.

    PubMed 12964668
  • Heermann JA, Wilson ME, Wilhelm PA. Mothers in the NICU: outsider to partner. Pediatr Nurs. 2005 May-Jun;31(3):176-81, 200.

    PubMed 16060580
  • Dhillon AS, Albersheim SG, Alsaad S, Pargass NS, Zupancic JA. Internet use and perceptions of information reliability by parents in a neonatal intensive care unit. J Perinatol. 2003 Jul-Aug;23(5):420-4. doi: 10.1038/sj.jp.7210945.

    PubMed 12847540
  • Kowalski WJ, Leef KH, Mackley A, Spear ML, Paul DA. Communicating with parents of premature infants: who is the informant? J Perinatol. 2006 Jan 1;26(1):44-8. doi: 10.1038/sj.jp.7211409.

    PubMed 16292336
  • Garfield CF, Kerrigan E, Christie R, Jackson KL, Lee YS. A Mobile Health Intervention to Support Parenting Self-Efficacy in the Neonatal Intensive Care Unit from Admission to Home. J Pediatr. 2022 May;244:92-100. doi: 10.1016/j.jpeds.2022.01.004. Epub 2022 Jan 13.

    PubMed 35033562
  • Garfield CF, Lee YS, Warner-Shifflett L, Christie R, Jackson KL, Miller E. Maternal and Paternal Depression Symptoms During NICU Stay and Transition Home. Pediatrics. 2021 Aug;148(2):e2020042747. doi: 10.1542/peds.2020-042747. Epub 2021 Jun 18.

    PubMed 34341101

Questions about this trial

What is this clinical trial studying?

A study testing Group 2: NICU2HOME app and Group 3: SMART NICU2HOME app in people with Premature Infant and Premature Birth, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome measure will be the level of confidence caring for their premature infants while in the NICU and once at home measured through a survey. (time frame: 2-3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03505424, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.

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